Some Local Country Regs

  • France
ANSM
CCTIRS
CNIL
RGPD
CNOM
CPP
– Link to French Legislations site

 

  • Germany
– Link to DIMDI submission site :
http://www.dimdi.de/static/en/mpg/index.htm
-Link to applicable legislation in Germany :
English version
German version

 

  • Switzerland

– ADMIN.CH :
http://www.admin.ch/ch/f/rs/c812_21.html
http://www.admin.ch/ch/f/rs/c812_213.html

  • UK
– Link to MHRA Clinical device regulations : http://www.mhra.gov.uk/Howweregulate/Devices/Clinicaltrials/index.htm
– Link to MHRA and applicable regulations for Medical Devices : https://www.gov.uk/government/publications/report-a-non-compliant-medical-device-enforcement-process/how-mhra-ensures-the-safety-and-quality-of-medical-devicesf
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Clinical research Consultants is a clinical and regulatory affairs CRO, based in central Paris, with activities throughout EU, US, Asia and the Middle East. CC Clinical research Consultants is particularly focused on compliance to moral, legal and scientific integrity. The company ensures full compliance with GCPs, ethical, legal and regulatory requirements governing the conduct of clinical research worldwide.